Orthosis, related components and methods of use

ABSTRACT

An orthosis, and components thereof, that may be used as a shoulder brace for immobilization of the arm and shoulder joint may comprise components that may allow for abduction, internal/external rotation and allow for flexion and extension simultaneously. Methods of using the brace and methods of using the brace and treating shoulder injuries are similarly provided.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.15/863,589, filed on Jan. 5, 2018, which claims the benefit of U.S.Provisional Application No. 62/443,572, filed Jan. 6, 2017, the entirecontents of each are hereby incorporated by reference in their entiretyherein.

BACKGROUND Field of the Disclosure

Injuries to the arm and shoulder require various braces that allow forvarious movement to provide a therapeutic angle or to prevent atrophy.When a patient is required to abduct the affected arm relative to thesagittal plane, some braces require separate bulky wedge(s) or pillowsto vary the abduction angle, which is cumbersome. Some braces may beequipped to fix the angle at only a certain number of angles without theflexibility to choose an angle that may be best for the patient. Otherbraces include a bendable metal part that can be deformed to a requiredtherapeutic angle but which may fatigue and crack over time and mayprevent the user from achieving the required therapeutic angle. Bendablemetal may also be unstable at larger angles and may require the use ofwedges or pillows to keep a therapeutic angle in a fixed position.

Similarly, when a patient is required to internally or externally rotatethe affected forearm relative the sagittal plane, wedges, pillows or abendable metal may be used to provide an internal/external rotationangle but the metal may similarly fatigue over time.

For patients who require their shoulder to be immobilized due toshoulder injuries, slings are not equipped to immobilize the shoulder,that is, to prevent shoulder flexion and extension. Slings also preventa patient from performing exercises, such as forearm flexion andextension, to prevent atrophy while immobilizing the shoulder to preventshoulder flexion and extension. If the sling is removed to perform rangeof motion or pendulum exercises, the shoulder may move to an undesirableposition.

Simultaneously accommodating movements such as abduction, internal andexternal rotation, and flexion and extension while immobilizing theshoulder may require multiple devices. In addition, different braces maybe necessary to accommodate either a left or a right arm. Various sizepatients need various sized braces to accommodate, for example, variousarm lengths, torso sizes, and heights. Further, some braces have screwsand other fasteners that require using tools to adjust the size of thebrace, which is cumbersome and difficult for patients having the use ofonly one unaffected arm.

Moreover, when a patient does not have the use of an arm, difficultyarises when attempting to position an orthosis having the use of asingle unaffected arm, without the help of another person.

It would be useful in the art to overcome one or more of theaforementioned problems.

SUMMARY

According to some embodiments, a lockable orthosis assembly is provided.The lockable orthosis assembly includes an internal/external rotationpivot hub defining an axial hub opening. The lockable orthosis assemblyincludes a hub base plate defining a plate opening, the hub base platepivotally engaged with the internal/external rotation pivot hub. Thelockable orthosis assembly includes a panel defining a panel opening andhaving at least one hub base plate adjustment receiver proximate thepanel opening. The lockable orthosis assembly includes a hub lock knobdefining a mating opening. The lockable orthosis assembly includes a hublock down axially disposed through the axial hub opening, the plateopening, and the panel opening. The hub lock down includes a mating endmated to the mating opening of the hub lock knob. The panel is disposedbetween the hub base plate and the hub lock knob. An assembly of the hublock down, internal/external rotation pivot hub, hub base plate, and hublock knob is translatably engaged through the panel opening of the atleast one hub base plate adjustment receiver of the panel.

The hub base plate may further include a slide member. The panel mayfurther include at least one hub base plate adjustment receiverproximate said hub lock knob. The lockable orthosis assembly may furtherinclude a lower hub washer disposed between the panel and the hub lockknob. In some aspects, the lockable orthosis assembly may furtherinclude a washer proximate a distal end of the hub lock knob. Theinternal/external rotation pivot hub may further define, in someaspects, a plurality of teeth pivotally engaged to a plurality ofopposing teeth defined in the hub base plate. The hub lock knob mayfurther include uni-directional gear teeth; wherein the lower hub washeris has a key portion. The internal/external rotation pivot hub may be aball in some aspects. Further, the hub base plate may be a socket base.The hub lock knob may be a locking torque knob. The hub lock down may bea lock down screw. When in use, the internal/external rotation pivot hubmay pivotally engage the hub base plate and may be lockable at any oneof a plurality of predetermined indexing points or friction interface.

A multi pivoting interface may include in some aspects the lockableorthosis assembly herein and may further include an upper arm supportcoupled to the hub lock down; and a forearm support rotationally engagedwith the upper arm support wherein at least a portion of the forearmsupport is disposed between the upper arm support and theinternal/external rotation pivot hub. For example, according to someaspects, the multi pivoting interface includes a lockable orthosisassembly including an internal/external rotation pivot hub defining anaxial hub opening. The assembly includes a hub base plate defining aplate opening, the hub base plate pivotally engaged with theinternal/external rotation pivot hub. The assembly includes a paneldefining a panel opening and having at least one hub base plateadjustment receiver proximate the panel opening. The assembly includes ahub lock knob defining a mating opening. The assembly includes a hublock down axially disposed through the axial hub opening, the plateopening, and the panel opening, the hub lock down including a mating endmated to the mating opening of the hub lock knob. The panel is disposedbetween the hub base plate and the hub lock knob. An assembly of the hublock down, the internal/external rotation pivot hub, the hub base plate,and the hub lock knob is translatably engaged through the panel openingof the at least one hub base plate adjustment receiver of the panel. Themulti pivoting interface includes an upper arm support coupled to thehub lock down. The multi pivoting interface includes a forearm supportrotationally engaged with the upper arm support wherein at least aportion of the forearm support is disposed between the upper arm supportand the internal/external rotation pivot hub.

The hub lock down may be at least partially recessed in the axial hubopening. In some aspects, the upper arm support may be coupled by arivet to the hub lock down. The internal/external rotation pivot hub mayfurther define at least one perpendicular hub opening. The upper armsupport may have an upper arm support hub end defining at least oneperpendicular arm support opening. The at least one perpendicular hubopening and the at least one perpendicular arm support opening may bealigned in some aspects. The rivet may be disposed through the at leastone perpendicular hub opening and the at least one perpendicular armsupport opening.

In some aspects, the multi pivoting interface may include an arm bracelock longitudinally disposed within the forearm support. The forearmsupport may include a forearm support hub end defining a forearm hublock opening. The upper arm support may include an upper arm support hubend defining at least one arm support hub lock opening. In some aspects,the arm brace lock may be releasably engaged with the forearm supportthrough the forearm hub lock opening and the upper arm support throughthe at least one arm support hub lock opening.

In some aspects, the multi pivoting interface may further include awrist support assembly adjustably engaged with the forearm support. Thewrist support assembly may include at least one wrist bar retractablyengaged with the forearm support, and a wrist shell removeably engagedwith the at least one wrist bar. The multi pivoting interface mayfurther include, in some aspects, a lock switch transversely alignedwith the longitudinal axis of the at least one wrist bar and moveablyengaged with the arm brace lock. The multi pivoting interface mayfurther include a stay and a fastener, such as a rivet and a washer, andthe wrist shell may be fastened to the stay with the fastener. The staymay define a fastener opening. The wrist shell may define a rivetopening and a stay opening. The rivet may be disposed through thefastener opening of the stay and the rivet opening. In some aspects, themulti pivoting interface may further include a forearm cover at leastpartially enclosing the arm brace lock between the forearm cover and adistal end of the forearm support.

In some embodiments, an orthopedic shoulder device may include the multipivoting interface herein. The panel may be an abduction support paneland the device may further include a rigid hinged frame including theabduction support panel coupled to a torso support panel through alocking abduction hinge, such as a positive locking hinge. For example,the orthopedic shoulder device includes a multi pivoting interfaceincluding a lockable orthosis assembly including an internal/externalrotation pivot hub defining an axial hub opening. The assembly includesa hub base plate defining a plate opening, the hub base plate pivotallyengaged with the internal/external rotation pivot hub. The assemblyincludes a panel defining a panel opening and having at least one hubbase plate adjustment receiver proximate the panel opening. The assemblyincludes a hub lock knob defining a mating opening. The assemblyincludes a hub lock down axially disposed through the axial hub opening,the plate opening, and the panel opening, the hub lock down including amating end mated to the mating opening of the hub lock knob. The panelis disposed between the hub base plate and the hub lock knob. Anassembly of the hub lock down, the internal/external rotation pivot hub,the hub base plate, and the hub lock knob is translatably engagedthrough the panel opening of the at least one hub base plate adjustmentreceiver of the panel. The multi pivoting interface includes an upperarm support coupled to the hub lock down. The multi pivoting interfaceincludes a forearm support rotationally engaged with the upper armsupport wherein at least a portion of the forearm support is disposedbetween the upper arm support and the internal/external rotation pivothub. The orthopedic shoulder device includes a rigid hinged frameincluding the abduction support panel coupled to a torso support panelthrough a locking abduction hinge.

The locking abduction hinge may include a torso hinge releasably engagedwith a lock shaft on a first distal end of the locking abduction hinge.The locking abduction hinge may include a free rotation hinge on asecond distal end of the locking abduction hinge. The torso hinge andthe lock shaft may be axially aligned with the free rotation hinge. Thelocking abduction hinge may include at least a portion of a spring maybe axially disposed between the lock shaft and the free rotation hinge.

The locking abduction hinge may include a right torso hinge releasablyengaged with a right lock shaft on a right distal end of the lockingabduction hinge. The locking abduction hinge may include a left torsohinge releasably engaged with a left lock shaft on a left distal end ofthe locking abduction hinge, The left torso hinge and the left lockshaft may be axially aligned with the right torso hinge and the rightlock shaft. The locking abduction hinge may include at least a portionof at least one spring may be axially disposed between the right lockshaft and the left lock shaft.

In some aspects, the orthopedic shoulder device may include an edge ofthe abduction support panel that defines an axial edge opening andopposing edge teeth on at least one end of the axial edge opening andmay be axially aligned with the lock shaft. The torso hinge may define atorso hinge opening and torso hinge opposing teeth. The lock shaft maydefine shaft teeth engagingly coupled to the opposing edge teeth and thetorso hinge opposing teeth.

In some aspects, the orthopedic shoulder device may include an edge thatdefines a right edge opening and right opposing edge teeth, and a leftedge opening and left opposing edge teeth on each end of the axial edgeopening. The torso hinge may define a right torso hinge opening andright torso hinge opposing teeth, and a left torso hinge opening andleft torso hinge opposing teeth. A right lock shaft may define rightshaft teeth engagingly coupled to the right opposing edge teeth and theright torso hinge opposing teeth. A left lock shaft may define leftshaft teeth engagingly coupled to the left opposing edge teeth and theleft torso hinge opposing teeth.

The torso support panel may define a right perpendicular opening on aright end of the torso support panel and a left perpendicular opening ona left end of the torso support panel; the right torso hinge may furtherdefine a right protrusion disposed within the right perpendicularopening; and the free rotation hinge further may define a leftprotrusion disposed within the left perpendicular opening.

The torso support panel may define a right perpendicular opening on aright end of the torso support panel and a left perpendicular opening ona left end of the torso support panel, the right torso hinge further maydefine a right protrusion disposed within the right perpendicularopening; and the left torso hinge further may define a left protrusiondisposed within the left perpendicular opening. The torso support panelmay include an alterable distal end.

In some aspects, the orthopedic shoulder device may further include avest at least partially enclosing the torso support panel and having anadjustable belt and/or may further include an upper arm support cover atleast partially enclosing the upper arm support; a forearm support coverleast partially enclosing the forearm support; an upper arm securingmember secured to the upper arm support cover; and a forearm securingmember secured to the forearm support cover.

In some aspects, the orthopedic shoulder device may further include awrist assembly cover at least partially enclosing the wrist assembly;and a hand securing member secured to the wrist assembly cover. In someaspects, the orthopedic shoulder device may further include a condylecover at least partially covering the upper arm support hub end or theforearm support hub end.

Methods may include using the lockable orthosis assembly herein. In someaspects, a method may include locking a position of theinternal/external rotation pivot hub in the hub base plate at a selectedangle, and sliding the at least one slide member along the at least onehub base plate adjustment receiver of the panel. The methods may furtherinclude rotating the forearm support hub end in relation to the upperarm support hub end to position an angle between the upper arm supportand the forearm support, and locking the forearm support at a selectedangle. The rotating step may further include accommodating an angleuseful for an opposite arm. The method may further include adjusting thewrist support assembly to a retracted or extended position.

In some aspects, the method of using the orthopedic shoulder brace mayinclude adjusting the locking abduction hinge; and locking the lockingabduction hinge at a selected angle between the abduction support paneland the torso support panel. In some aspects, the method of using theorthopedic shoulder includes positioning the orthopedic shoulder braceon a patient, using only an uninjured arm in the positioning step.

Other features and advantages will be apparent from the followingdetailed description, the drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exploded view including the hinged abductionassembly, the pivot assembly, and an aspect for accommodating variousarm lengths, according to some example embodiments;

FIG. 2 illustrates an exploded view of the assemblies for the upper arm,forearm and wrists, including the rotating, according to some exampleembodiments;

FIG. 3A illustrates an exploded view and partially exploded view 3B ofan aspect of an orthosis assembly including the upper arm and forearmassembly, according to some example embodiments;

FIG. 4 illustrates an exploded view of a wrist assembly, according tosome example embodiments;

FIG. 5 illustrates a perspective view of a knob assembly, according tosome example embodiments;

FIG. 6 illustrates a perspective view including a ball and socketinterface, according to some example embodiments;

FIG. 7 illustrates an exploded view including a ball and socketinterface, according to some example embodiments;

FIG. 8 illustrates a perspective view including a pivot interface,according to some example embodiments;

FIG. 9 illustrates a perspective view of an orthosis assembly, accordingto some example embodiments;

FIG. 10 illustrates a perspective view of an orthosis assembly with agarment that houses the assembly, according to some example embodiments;

FIG. 11 illustrates the arm/brace pivot axis, where the arrows suggestthe movement of the arm flexion and extension, according to some exampleembodiments;

FIG. 12A illustrates internal rotation, according to some exampleembodiments;

FIG. 12B illustrates external rotation, according to some exampleembodiments;

FIG. 13 shows an arm abduction angle between the torso and the supperarm, and the brace angle between the torso support panel and theabduction support panel, according to some example embodiments. Thehinge does not reach the armpit of the wearer and thus is morecomfortable than conventional abduction apparatuses such as wedges thatcause discomfort when the brace is in direct contact with the armpit.

DETAILED DESCRIPTION

Aspects of the present orthosis may overcome at least some or all of theproblems associated with conventional shoulder braces. In one aspect,the shoulder brace or orthosis herein provides shoulder immobilizationto aid in post-surgical rehabilitation involving the affected shoulderjoint. In one embodiment, the orthosis is designed to provide theability to perform one or more of the following functions: a) providethe patient the ability to abduct the affected arm relative to thesagittal plane of the individual from about 0° (neutral) to 90°, inpre-determined increments, in some aspects without the use of separatebulky wedges or bendable metal to obtain the angle; b) provide internalrotation of the forearm relative to the sagittal plane of the individualin predetermined increments, in some aspects without the use of bendablemetal to obtain the angle; c) provide external rotation of the forearmrelative to the sagittal plane of the individual in predeterminedincrements; and/or provide forearm flexion and extension mobility whilethe shoulder brace is positioned on the individual, in some aspectswhile immobilizing the shoulder (i.e., preventing shoulder flexion orextension) so that lower arm movement or exercise may be performed.

In some embodiments, multiple pathologies can be addresses with oneorthosis, including, but not limited to: glenohumeral dislocation orsubluxation, capsular shifts, posterior shoulder stabilizations, Bankartrepairs, release severe anterior capsule contracture, soft tissuestrains or repairs, rotator cuff repairs, total shoulder replacement,superior labral repairs (SLAP), shoulder debridement, fractures(humerus, elbow, forearm), biceps tendon repair, elbow ligament/tendonrepair, anterior shoulder lauxation and AC joint reconstruction.

The patient may be required to perform internal or external rotation ofthe forearm during rehabilitation. In one embodiment, an assembly mayprovide a brace or a portion of a brace that will have a mechanism thatallows internal and external rotation and at the same time allowing thebrace to be adjusted to fit a patient's arm length as the upper armlength varies from person to person. The same brace has, in someaspects, the ability to adjust to accommodate various arm lengths.

Turning to the drawings, wherein like reference numerals refer to likeelements, techniques of the present disclosure are illustrated as beingimplemented in a suitable environment. The following description isbased on embodiments of the claims and should not be taken as limitingthe claims with regard to alternative embodiments that are notexplicitly described herein.

With reference to FIG. 1, an internal/external rotation pivot hub 1defines an axial hub opening 2 and is pivotally engaged with a hub baseplate 3 that defines a plate opening 4. The assembly allows for lockableadjustment when performing internal or external rotation of the forearm.The internal/external rotation pivot hub 1, in some aspects, may definea plurality of teeth 17 pivotally engaged to a plurality of opposingteeth 18 defined in the hub base plate 3. This embodiment provides theability for adjustment at predetermined intervals or angles (i.e.,indexing points). The teeth or slots may be indexed at various anglessuch as 15° each to internally or externally rotate 15°, 30°, or 45°.Microindexing or infinite indexing is difficult but not impossible toachieve with teeth or slots because the material to make the teeth orslots must be made thinner to accommodate smaller angle changes and thematerial may become weaker. Angular displacement may also be achievedwith a hinge. Alternatively, as shown in embodiments in FIGS. 6 and 7,the internal/external rotation pivot hub 1 may be a ball 1 a, and thehub base plate 3 may be a socket base 3 a. A ball joint (or similarmechanism) can be utilized for infinite adjustability. In oneembodiment, locking the ball to the socket base 3 a relies on thefriction interface between the two surfaces. By adding a more aggressive“bite” from one surface to the adjacent, the hold will increasesignificantly.

FIG. 7 illustrates an embodiment where the hub lock knob 8 is a lockingtorque knob 8 a, and the hub lock down 10 is a lock down screw 10 a.When in use, in some aspects, the internal/external rotation pivot hub 1pivotally engages the hub base plate 3 and is lockable at any one of aplurality of predetermined indexing points or friction interface, byusing the hub lock knob 8, such as the locking torque knob 8 a. In someaspects, the rotation is about 45° from neutral in either the internalor external rotation therefore the entire swing may be about 90°. Inadditional aspects, locking torque knob 8 a can be replaced with anotherhub lock mating member or other means of tightening the assembly, suchas a screw/nut, cam lock, a compression spring holding mating geartogether, or a ratcheting mechanism.

The hub base plate 3 may further comprise a slide member 13, as shown inFIG. 1. FIG. 1 also shows a panel 5, such as an abduction support panel5 a, that defines a panel opening 6 and has at least one hub base plateadjustment receiver 7 proximate the panel opening 6. A hub lock matingmember such as a hub lock knob 8 defines a mating opening 9. Through theopenings mentioned above, a hub lock down 10 is axially disposed, i.e.,through the axial hub opening 2, the plate opening 4, and the panelopening 6. The hub lock down 10 comprises a mating end 11 mated to themating opening 12 of the hub lock knob 8. The panel 5 is disposedbetween the hub base plate 3 and the hub lock knob 8. An assembly of thehub lock down 10, internal/external rotation pivot hub 1, hub base plate3, and hub lock knob 8 is translatably engaged through the panel opening6 of the at least one hub base plate adjustment receiver 7 of the panel5. In this embodiment, the assembly allows the angle for the internal orexternal rotation of the forearm to be adjusted while simultaneouslylocking the selected arm length into position.

In one aspect, the hub lock knob 8 rotates freely, for example clockwise, to tighten the assembly. The lockable orthosis assembly mayfurther comprise a lower hub washer 14 disposed between the panel 5 andthe hub lock knob 8. FIG. 5 shows more detail of an aspect of the lowerhub washer 14 and the hub lock knob 8, where the hub lock knob 8 furthercomprises uni-directional gear teeth 17 a and the lower hub washer 14has a key portion 19. In some aspects, the key portion 19 is integral tothe lower hub washer 14. The key portion 19 of the lower hub washer 14prevents the hub lock knob 8 from rotating, for example,counterclockwise freely (if the assembly was tightened clockwise) andlost the key portion 19 is depressed upward allowing the unidirectionalgear teeth 17 a of the hub lock knob 8 to rotate freelycounterclockwise.

On the side of the hub lock knob 8 opposite the lower hub washer 14, thelockable orthosis assembly may further comprise a washer 15, which isproximate a distal end 16 of the hub lock knob 8, as shown in FIG. 1.

Methods of using the orthosis assembly include locking a position of theinternal/external rotation pivot hub 1 in the hub base plate 3 at aselected angle; and sliding the at least one slide member 13 along theat least one hub base plate adjustment receiver 7 of the panel 5 toadjust for arm length.

The internal/external rotation pivot hub 1, may be positioned at anglesfrom 0° to 90° or more and any degree or fraction of a degree inbetween. However, the limits of the material may necessitate a largerangle of change so that each tooth, for example retains its integritywithout breaking. Infinite angles although possible, may not bepractical based on the material used, such as a plastic that may breakif the teeth that provide the angle are too thin.

In some embodiments, the orthosis comprises a multi pivoting interface.The multi pivoting interface allows for alignment to patient anatomy andto preset the internal and external rotation of the patient's forearm.In some aspects, such as in FIGS. 2 and 3A, the multi pivoting interfacecomprises an upper arm support 20 coupled to the hub lock down 10; and aforearm support 21 rotationally engaged with the upper arm support 20wherein at least a portion of the forearm support 21 is disposed betweenthe upper arm support 20 and the internal/external rotation pivot hub 1.When in use, in some aspects, the arm brace pivots naturally inalignment to the elbow joint. Further, in some embodiments, for example,in FIG. 3B, the hub lock down 10 is at least partially recessed in theaxial hub opening 2. FIGS. 1 and 3A show certain embodiments where theupper arm support 20 is coupled by a rivet 22 to the hub lock down 10.The assembly may also comprise, in some aspects such as shown in FIG. 2,a forearm cover 34 at least partially enclosing the arm brace lock 29between the forearm cover 34 and a distal end 35 of the forearm support21.

FIGS. 1, 3A and 3B also illustrate an embodiment wherein theinternal/external rotation pivot hub 1 further defines at least oneperpendicular hub opening 23; the upper arm support 20 having an upperarm support hub end 24 defining at least one perpendicular arm supportopening 25; the at least one perpendicular hub opening 23 and the atleast one perpendicular arm support opening 24 are aligned; and therivet 22 is disposed through the at least one perpendicular hub opening24 and the at least one perpendicular arm support opening 25.

In some aspects, the arm brace comprises a locking feature that locksthe arm brace to the desired angular setting for normal daily use toprovide support to the affected arm. The patient may disengage the lockon the brace to provide controlled flexion and extension of the arm asdirected by a medical professional. The arm brace may be unlocked invarious ways. For example, the arm brace may be unlocked using a lockswitch on the brace.

The arm brace may be positioned for form an angle between the upper armsupport 20 and the forearm support 21. In some aspects, the angles maybe adjustable at least 180° to accommodate the position of a patient'sleft or right arm. Thus, the left or right arm may be positioned atneutral position (forearm is close to parallel to the sagittal plane andaxial plane). Although the forearm at neutral is about 90° relative tothe upper arm, in contrast, relative to neutral, the forearm would bepositioned at 0° and would accommodate an angle of at least 180° fromthe neutral position to accommodate a right neutral arm position or aleft neutral arm position depending on which arm the patient istreating, and in some aspects locks in place at 0° or 180° depending onthe arm being treated. The angle may be adjusted at any degree orfraction of a degree at least in between 0° to 180°. In some aspects,the range of motion may also be accommodated by adding additional anglesfor flexion that may be adjusted such as 30-45° above neutral. Whenunlocked, the arm will hang down towards the floor when standing and mayremain unlocked is some aspects. When unlocked, the forearm support canbe moved in either direction and lock in neutral position.

FIG. 2 illustrates an embodiment comprising an arm brace lock 29 thatmay be longitudinally disposed within the forearm support 21. (The armbrace lock 29, in a different embodiment, may be in the upper armsupport, however, the arm brace lock 29 may be easier to use when it isin the forearm support 21.) In one aspect, the forearm support 21comprises a forearm support hub end 26 defining a forearm hub lockopening 27; and the upper arm support 20 comprises an upper arm supporthub end 24 defining at least one arm support hub lock opening 28. Thearm brace lock 29 may releasably engaged with the forearm support 21through the forearm hub lock opening 27 and the upper arm support 20through the at least one arm support hub lock opening 28.

Methods may include rotating the forearm support hub end 26 in relationto the upper arm support hub end 24 to position an angle between theupper arm support 20 and the forearm support 21; and locking the forearmsupport 21 at a selected angle. In some aspects, the orthosis isreversible and therefore the rotating step may further compriseaccommodating an angle useful for the opposite arm.

Alternatively, or in addition, the arm brace may be unlocked byretracking a wrist support assembly 30 into the brace. FIGS. 2 and 4show an aspect of the orthosis comprising a wrist support assembly 30that may be adjustably engaged with the forearm support 21. The wristsupport assembly 30 may comprise, in some aspects, at least one wristbar 31 retractably engaged with the forearm support 21; and a wristshell 32 removeably engaged with the at least one wrist bar 31. Thelocking aspect may also comprise a lock switch 33 being transverselyaligned with the longitudinal axis of the at least one wrist bar 31 andmoveably engaged with the arm brace lock 29. Thus, the lock switch 33offers the patient the ability to quickly disengage the lock to allowfor instant mobility. In some aspects, when the brace is returned to theinitial setting (i.e., neutral setting, where the forearm is parallel tothe sagittal and axial planes) the brace automatically re-locks intoposition. The re-tracked wrist support allows the patient to keep thearm brace unlocked for an extended period of time (to accommodate forexercise or longer activity) and will re-lock only when the wristsupport is extended out of the retracted position. In some aspects, thetelescoping wrist support provides support to the wrist during daily useand can be positioned to a desired length as required by the end user byadjusting the wrist support assembly 30 to a retracted or extendedposition. The wrist support may be retractable so lower arm exercisesmay be performed allowing for range of motion exercises.

The wrist support assembly 30 may further comprise, in some aspects, astay 52 and a fastener 54, wherein the wrist shell 32 may be fastened tothe stay 52 with the fastener 53, such as a rivet 54 a and a washer 54b, as illustrated in the exploded view in FIG. 4. In some aspects, thestay 52 defines a fastener opening 55 and the wrist shell 32 defines arivet opening 56 and a stay opening 57; wherein the rivet 54 a isdisposed through the fastener opening 55 of the stay 52 and the rivetopening 56. In use, the wrist shell 32 may be made from material such aspolypropylene that may bend and conform to a patient's wrist, it mayslowly lose its shape if left to flatten. The stay 52 such as a metalstay of aluminum or another bendable material may be also bend to shapearound the wrist, but will retain its shape more than e.g. apolypropylene shell.

In some aspects, the wrist support comprises a removable interchangeablehand rest component that may be removed and rotated to accommodateeither the left or the right wrist. For example, the wrist shell 32 maybe configured to accept the wrist bar 31, which may snap in place in thewrist shell 32 in either direction, i.e., when the wrist shell 32 isrotated 180°.

In some aspects, the orthosis comprises a shoulder brace that may bepositioned around the mid-torso region. In some embodiments, thepivoting alignment of the platform does not align with the shoulderjoint. In some aspects, this offset allows the arm brace to align to thepatient's arm independent of the platform angle. A semi-restrictedmovement is provided in the arm brace-frame interface to accommodate forthis angle offset. More particularly, the internal/external rotation hub1 may have semicircular slots 67 on either side for receivingsemicircular members 68 from the upper arm support 20. This allows theupper arm support 20 to self align with the shoulder joint.

In some embodiments, the frame of the shoulder brace may comprise twoloading platforms or panels, one (e.g., the panel 5 or abduction supportpanel 5 a) may mechanically lock and support an arm brace and the other(e.g., the torso support panel 36) may be utilized as a leverage surfaceto support a position in space and rest on the torso. These platforms orpanels may be made of various materials and may have various shapes. Forexample, the platforms may be rigid or semi-rigid and can be flat or intubular form or may be molded. In some aspects, the torso support panel36, may be made from trimmable material, may have pre-stressed regions,or break lines so that the panel may be cleanly broken, and thereforemay be adjusted to fit various torso lengths and heights of patients.For example, in FIG. 1 the torso support panel 36, in some aspects, maycomprise an alterable distal end 51.

The frame aids in the positioning of the arm brace relative to thepatient's sagittal plane. In some aspects, the frame and arm brace aremechanically attached and the frame strategically transfers the load ofthe patient's arm to the torso. The frame may remain staticallypositioned on the patient's torso with the utilization of the garment,described below, and leverages this positioning to maintain stability ofthe shoulder while abducting, internally/externally rotating, and/or orwhile flexing or extending the forearm.

The frame may be made of various materials such as lightweight materials(for example, metals or plastics).

When in use, the frame may be collapsible enough to allow the patientthe ability to closely achieve 0° (neutral) abduction. In someembodiments, the pivoting angle of the frame sits horizontally below thenatural pivoting center of the shoulder, and thus the frame may allowfor angles larger than 90°, such as 110° to 120° (although it could beextended farther), if for example, a patient wears the brace lower onthe torso, to allow the true abduction positioning of the shoulder jointof 90° as shown in FIG. 13. Allowing angles to be larger, although notprevented, may find few uses or benefits related to abduction, e.g.,allowing for 180°.

In some aspects, the locking abduction hinge 37 is capable of lockinginto predetermined angles with the use of one or more positive lockhinges. Hinges that have pins or other hinges such as in US Pat. Publ.2011/0314637 may also be used. The shoulder brace portion of theorthosis, in some aspects, may comprise rigid hinged frame comprising apanel 5 such as the abduction support panel 5 a coupled to a torsosupport panel 36 through a locking abduction hinge 37, such as apositive locking hinge, for example, as shown in FIG. 1. In in oneembodiment, the locking abduction hinge 37 comprises a torso hinge 38releasably engaged with a lock shaft 39 on a first distal end 40 a ofthe locking abduction hinge 37. The opposite side of the lockingabduction hinge 37 may comprise a free rotation hinge [not shown] on asecond distal end 40 b of the locking abduction hinge 37. In someaspects, the torso hinge 38 and the lock shaft 39 are axially alignedwith the free rotation hinge [not shown]; and at least a portion of aspring 41 axially disposed between the lock shaft 39 and the freerotation hinge [not shown]. In some aspects, the torso hinge 38 definesa torso hinge opening 46 and torso hinge opposing teeth 47; and the lockshaft 39 defines shaft teeth 44 engagingly coupled to the opposing edgeteeth 45 and the torso hinge opposing teeth 47. In some aspects, thetorso support panel 36 may define a right perpendicular opening 50 a ona right end 48 a of the torso support panel 36 and a left perpendicularopening 50 b on a left end 48 b of the torso support panel. The righttorso hinge 38 a further may define a right protrusion 49 a disposedwithin the right perpendicular opening 50 a. The free rotation hinge[not shown] further may define a left protrusion 49 b disposed withinthe left perpendicular opening 50 b.

More stable abduction may be achieved, for example, when the lockingabduction hinge 37 comprises a right torso hinge 38 a releasably engagedwith a right lock shaft 39 a on a right distal end 40 a of the lockingabduction hinge 37; and a left torso hinge 38 b releasably engaged witha left lock shaft 39 b on a left distal end of the locking abductionhinge 37, as shown in FIG. 1. The left torso hinge 38 b and the leftlock shaft 39 b maybe axially aligned with the right torso hinge 38 aand the right lock shaft 39 a.

Further, in some aspects, at least a portion of at least one spring 41(such as 2 springs) is axially disposed between the right lock shaft andthe left lock shaft. One spring and one lock shaft may also be used.

As shown in FIGS. 1 and 9, the locking abduction hinge 37 maybe locatedproximate an edge 42 of the abduction support panel 5 that defines anaxial edge opening 43, that may be axially aligned with the lock shaft39. The abduction support panel 5 may also define opposing edge teeth 45on at least one end of the axial edge opening 43. In furtherembodiments, the edge 42 may define a right edge opening 43 a and rightopposing edge teeth 45 a, and a left edge opening 43 b and left opposingedge teeth 45 b on each end of the axial edge opening 43. In someaspects, the torso hinge 38 may define a right torso hinge opening 46 aand right torso hinge opposing teeth 47 a, and a left torso hingeopening 46 b and left torso hinge opposing teeth 47 b. Further, a rightlock shaft 39 a may define right shaft teeth 44 a engagingly coupled tothe right opposing edge teeth 45 a and the right torso hinge opposingteeth 47 a; and a left lock shaft 39 b may define left shaft teeth 44 bengagingly coupled to the left opposing edge teeth 45 b and the lefttorso hinge opposing teeth 47 b. Some aspects, the torso support panel36 may define a right perpendicular opening 50 a on a right end 48 a ofthe torso support panel 36 and a left perpendicular opening 50 b on aleft end 48 b of the torso support panel 36. The right torso hinge 38 afurther may define a right protrusion 49 a disposed within the rightperpendicular opening 50 a and the left torso hinge 38 b further maydefine a left protrusion 49 b disposed within the left perpendicularopening 50 b.

When in use, for example, an individual may depress one or more of thecenter buttons to allow the hinge to index to the desired angularsetting and releasing the button will allow the hinge to lock itselfinto position. Other similar types positive lock hinges can be used toaccomplish this positioning.

Methods may include adjusting the locking abduction hinge 37; andlocking the locking abduction hinge 37 at a selected angle between theabduction support panel 5 and the torso support panel 36.

In some embodiments, the brace accommodates different patient sizes andweights, and therefore has universal fit unlike conventional braces. Byadjusting the straps and pads the brace can be easily sizes fordifferent anatomies. In addition, some aspects, the brace may be easilyswitched from a left to right arm application with the adjustment of,for example, straps, pads and by adjusting the angles of the arm andwrist supports.

In some aspects, the orthosis comprises a rigid structural frame and armbrace enclosed within a garment meant to be strapped and secured aroundthe patient's mid/lower torso. Comfortable padding enables the patientto don the brace for extended periods of time, inclusive of periods ofrest or sleep. The brace may also incorporate an optional shoulder strapthat may provide additional stability, weight distribution and/oradditionally prevent product migration. In one embodiment, FIG. 10 showsa vest 58 at least partially enclosing the torso support panel 36 andhas an adjustable belt 59.

To facilitate the user positioning the brace on the affected arm withthe one remaining functional arm, the soft interface (or soft paddingattached to the arm brace) may be lined with a malleable material so asto hold its shape (for example, at all times) and allow the end user toswiftly and with little effort slide the affected arm into the brace. Insome aspects, sufficient padding is provided to prevent discomfort tothe patient from this malleable material. The malleable material may bemade of a bendable plastic or metal that can be positioned and hold itsshape, such as a copper or aluminum wire or sheet having a sufficientgauge or strength to hold its shape but thin or flexible enough to bend.

In some embodiments, an arm brace comprises the upper arm support 20 andthe forearm support covered with a soft interface that may encapsulatethe upper arm and forearm to properly engage the patient's arm, forexample, when it is attached to the shoulder brace. The arm may besecured using padding and straps. When desired, some aspects, thecombination of strapping the arm in the arm brace and the frame to thetorso, restricts motion of the shoulder joint and minimizes shoulderjoint movement (retraction, protraction, depression, elevation). In oneembodiment, FIG. 10 shows an upper arm support cover 60 at leastpartially enclosing the upper arm support 20; a forearm support cover 61at least partially enclosing the forearm support 21; an upper armsecuring member 62 secured to the upper arm support cover 60; and aforearm securing member 63 secured to the forearm support cover 61. Theorthopedic shoulder device may also comprise a wrist assembly cover 64at least partially enclosing the wrist assembly 30; and a hand securingmember 65 secured to the wrist assembly cover 64. In some aspects, theorthopedic shoulder device comprises a condyle cover 66 at leastpartially covering the upper arm support hub end 24 or the forearmsupport hub end 26 near the condyle area or the elbow. In some aspects,the condyle cover 66 is separate from the forearm support cover.

A liner or soft goods which line the arm rigid materials of the bracemay be constructed from open or closed cell foam laminated with amoisture-wicking spacer fabric, polyethylene or EVA foam core, and/or amoisture wicking fabric laminated and/or breathable foam, and havesufficient padding so that the brace may be worn during sleep. Theliners may be made from spacer fabric or breathable open cell foam suchas post op knee liners, which may be made from polyurethane. Spacerfabric uses two separate fabrics, joined by microfilament yarn, tocreate a breathable, 3D “microclimate” between layers. The material mayalso include cooling portions or patches that pull heat away from thebody.

The soft goods can be attached via fasteners, such as, snaps, plasticrivets or hook and loop fasteners.

The orthopedic shoulder brace is easy to use and may be positioned by apatient, using only the unaffected arm. In some aspects, once theabduction angle is set, the internal and external rotation angle is set,the arm length and/or the torso length is adjusted, the orthosis may besecured to the patient's body using only the unaffected arm.

The phrases “connected to,” “coupled to” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be functionally coupled to each othereven though they are not in direct contact with each other.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

The word “othosis” or “orthotic” is used herein to mean a brace or othersuch device. Consequently, othosis may be used interchangeably with theterm “brace” and may refer to specific types of braces when indicated(e.g., a shoulder orthosis or shoulder brace).

The orthosis or parts thereof, may be formed of one or more sturdy,rigid, lightweight materials, such as metal or water-resistant materialsso that the orthosis can be used in a shower, bath, swimming pool, orother aqueous environment. The panels and/or supports or othercomponents of the frame may be injection molded constructed from nylon,ABS, polypropylene, a combination of nylon and polypropylene, or othersuitably strong plastic resin (e.g., polypropylene).

The word “neutral” is used herein to mean at or about zero degrees froma centermost position or plane. For example, with respect to forearmflexion or extension, neutral may refer to a plane roughly perpendicularto a user's spine. When positioning the arm from a user's body forabduction, neutral may refer to a plane roughly parallel to a user'sspine.

“Strap” generally refer to one or more fasteners such as flexiblestraps, buckles, clips, clasps, fasteners such as hook and loopfasteners, or other detachable elements or may refer to a band that maygrip a part of the anatomy. Hook and loop fastening systems (such as anarray of loops) may mate with a corresponding component on a surface ormay contain both mating components on a single strap. The straps in someaspects permit relatively rapid and easy attachment to and detachment.In some embodiments, the fasteners are coupled to the one or moreportions of the frame panels by threading them through holes, e.g., in apanel or arm support.

Reference throughout this disclosure to “an embodiment” or “theembodiment” or an aspect thereof means that a particular feature,structure or characteristic described in connection with that embodimentis included in at least one embodiment. Thus, the quoted phrases, orvariations thereof, as recited throughout this disclosure are notnecessarily all referring to the same embodiment or aspect.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, Figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim in this orany application claiming priority to this application require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

While specific embodiments and applications of the present disclosurehave been illustrated and described, it is to be understood that thedisclosure is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent disclosure disclosed herein without departing from the spiritand scope of the disclosure.

1-20. (canceled)
 21. A method of using a lockable orthosis assembly, themethod comprising: locking an internal/external rotation pivot hub ofthe lockable orthosis assembly at a first desired angle with respect toa pivotally engaged hub base plate of the lockable orthosis assembly,wherein the internal/external rotation pivot hub defines an axial hubopening and the hub base plate defines a plate opening; adjusting alocking abduction hinge of the lockable orthosis assembly that couples arigid hinged frame comprising a panel to a torso support panel, whereinthe panel of the rigid hinged frame defines a panel opening and has atleast one hub base plate adjustment receiver proximate the panelopening; and locking the locking abduction hinge such that the panel ofthe rigid hinged frame is disposed at a second desired angle withrespect to the torso support panel, wherein the lockable orthosisassembly further comprises: a hub lock knob defining a mating opening,and a hub lock down axially disposed through the axial hub opening, theplate opening, and the panel opening, the hub lock down comprising amating end mated to the mating opening of the hub lock knob; andwherein: the panel of the rigid hinged frame is disposed between the hubbase plate and the hub lock knob; and an assembly of the hub lock down,the internal/external rotation pivot hub, the hub base plate, and thehub lock knob is translatably engaged through the panel opening of theat least one hub base plate adjustment receiver of the panel.
 22. Themethod of claim 21, wherein: the hub base plate further comprises aslide member; and the at least one hub base plate adjustment receiver isdisposed proximate the hub lock knob, the method further comprisingsliding the slide member along the at least one hub base plateadjustment receiver.
 23. The method of claim 21, wherein theinternal/external rotation pivot hub further defines a plurality ofteeth pivotally engaged to a plurality of opposing teeth defined in thehub base plate.
 24. The method of claim 23, wherein the lockableorthosis assembly further comprises a lower hub washer having a keyportion and the hub lock knob further comprises uni-directional gearteeth.
 25. The method of claim 21, wherein: the internal/externalrotation pivot hub is a ball; and the hub base plate is a socket base.26. The method of claim 21, wherein: the hub lock knob is a lockingtorque knob; and the hub lock down is a lock down screw.
 27. The methodof claim 21, wherein, when in use, the internal/external rotation pivothub pivotally engages the hub base plate and is lockable at any one of aplurality of predetermined indexing points or at a friction interface.28. A method of using a multi pivoting interface, the method comprising:locking an internal/external rotation pivot hub of a lockable orthosisassembly of the multi pivoting interface at a first desired angle withrespect to a pivotally engaged hub base plate of the lockable orthosisassembly, wherein the internal/external rotation pivot hub defines anaxial hub opening and the hub base plate defines a plate opening;adjusting a locking abduction hinge of the lockable orthosis assemblythat couples a rigid hinged frame comprising a panel to a torso supportpanel, wherein the panel of the rigid hinged frame defines a panelopening and has at least one hub base plate adjustment receiverproximate the panel opening; and locking the locking abduction hingesuch that the panel of the rigid hinged frame is disposed at a seconddesired angle with respect to the torso support panel, wherein thelockable orthosis assembly further comprises: a hub lock knob defining amating opening, and a hub lock down axially disposed through the axialhub opening, the plate opening, and the panel opening, the hub lock downcomprising a mating end mated to the mating opening of the hub lockknob; wherein: the panel of the rigid hinged frame is disposed betweenthe hub base plate and the hub lock knob, and an assembly of the hublock down, the internal/external rotation pivot hub, the hub base plate,and the hub lock knob is translatably engaged through the panel openingof the at least one hub base plate adjustment receiver of the panel; andwherein the multi pivoting interface further comprises: an upper armsupport coupled to the hub lock down; and a forearm support rotationallyengaged with the upper arm support wherein at least a portion of theforearm support is disposed between the upper arm support and theinternal/external rotation pivot hub.
 29. The method of claim 28,wherein: the hub lock down is at least partially recessed in the axialhub opening; and the upper arm support is coupled by a rivet to the hublock down.
 30. The method of claim 28, wherein: the internal/externalrotation pivot hub further defines at least one perpendicular hubopening; the upper arm support has an upper arm support hub end definingat least one perpendicular arm support opening; the at least oneperpendicular hub opening and the at least one perpendicular arm supportopening are aligned; and a rivet is disposed through the at least oneperpendicular hub opening and the at least one perpendicular arm supportopening.
 31. The method of claim 28, wherein: the multi-pivotinginterface further comprises an arm brace lock longitudinally disposedwithin the forearm support; the upper arm support comprises an upper armsupport hub end defining at least one arm support hub lock opening; andthe arm brace lock is releasably engaged with the forearm supportthrough the forearm hub lock opening and the upper arm support throughthe at least one arm support hub lock opening.
 32. The method of claim28, wherein the multi-pivoting interface further comprises a wristsupport assembly adjustably engaged with the forearm support, the methodfurther comprising adjusting the wrist support assembly to one of aretracted position or a extended position.
 33. The method of claim 32,wherein the wrist support assembly comprises: at least one wrist barretractably engaged with the forearm support; and a wrist shellremoveably engaged with the at least one wrist bar.
 34. The method ofclaim 33, wherein the multi-pivoting interface further comprises a lockswitch transversely aligned with the longitudinal axis of the at leastone wrist bar and moveably engaged with an arm brace lock longitudinallydisposed within the forearm support.
 35. A method of using an orthopedicshoulder device, the method comprising: locking an internal/externalrotation pivot hub of a lockable orthosis assembly of a multi pivotinginterface of the orthopedic shoulder device at a first desired anglewith respect to a pivotally engaged hub base plate of the lockableorthosis assembly, wherein the internal/external rotation pivot hubdefines an axial hub opening and the hub base plate defines a plateopening; adjusting a locking abduction hinge of the lockable orthosisassembly that couples a rigid hinged frame comprising an abductionsupport panel, to a torso support panel, wherein the abduction supportpanel defines a panel opening and has at least one hub base plateadjustment receiver proximate the panel opening; and locking the lockingabduction hinge such that the abduction support panel is disposed at asecond desired angle with respect to the torso support panel, whereinthe lockable orthosis assembly further comprises: a hub lock knobdefining a mating opening, and a hub lock down axially disposed throughthe axial hub opening, the plate opening, and the panel opening, the hublock down comprising a mating end mated to the mating opening of the hublock knob; wherein: the abduction support panel is disposed between thehub base plate and the hub lock knob, and an assembly of the hub lockdown, the internal/external rotation pivot hub, the hub base plate, andthe hub lock knob is translatably engaged through the panel opening ofthe at least one hub base plate adjustment receiver of the panel; andwherein the multi pivoting interface further comprises: an upper armsupport coupled to the hub lock down, and a forearm support rotationallyengaged with the upper arm support wherein at least a portion of theforearm support is disposed between the upper arm support and theinternal/external rotation pivot hub.
 36. The method of claim 35,wherein the locking abduction hinge is a positive locking hinge.
 37. Themethod of claim 35, wherein the locking abduction hinge comprises: atorso hinge releasably engaged with a lock shaft on a first distal endof the locking abduction hinge; a free rotation hinge on a second distalend of the locking abduction hinge, wherein the torso hinge and the lockshaft are axially aligned with the free rotation hinge; and at least aportion of a spring axially disposed between the lock shaft and the freerotation hinge.
 38. The method of claim 35, wherein the lockingabduction hinge comprises: a right torso hinge releasably engaged with aright lock shaft on a right distal end of the locking abduction hinge; aleft torso hinge releasably engaged with a left lock shaft on a leftdistal end of the locking abduction hinge, the left torso hinge and theleft lock shaft are axially aligned with the right torso hinge and theright lock shaft; and at least a portion of at least one spring axiallydisposed between the right lock shaft and the left lock shaft.
 39. Themethod of claim 37, wherein: an edge of the abduction support paneldefines an axial edge opening and opposing edge teeth on at least oneend of the axial edge opening, the edge of the abduction support panelbeing axially aligned with the lock shaft; the torso hinge defines atorso hinge opening and torso hinge opposing teeth; and the lock shaftdefines shaft teeth engagingly coupled to the opposing edge teeth andthe torso hinge opposing teeth.
 40. The method of claim 38, wherein: anedge defines a right edge opening and right opposing edge teeth, and aleft edge opening and left opposing edge teeth on each end of the axialedge opening; the torso hinge defines a right torso hinge opening andright torso hinge opposing teeth, and a left torso hinge opening andleft torso hinge opposing teeth; a right lock shaft defines right shaftteeth engagingly coupled to the right opposing edge teeth and the righttorso hinge opposing teeth; and a left lock shaft defines left shaftteeth engagingly coupled to the left opposing edge teeth and the lefttorso hinge opposing teeth.